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NCT Number: NCT06852118

Using the Adductor Magnus Plain Block as an Innovative Approach for Sciatic Nerve Block for Lower Limb Surgeries.

the goal of this clinical trial is to compare the efficacy of adductor magnus muscle plane injection as an approach for sciatic nerve block to sub-gluteal approach in combination with femoral nerve blocks as perioperative analgesia in knee surgeries.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Adductor Magnus Plain Injection for Sciatic Nerve Block

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculity of medicine - Al-Azhar University hospitals

Cairo, Cairo Governorate, 11884, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA (American Society of Anaesthesiologists) Physical Status I-III.
  • Patients who consent to receive regional anesthesia.

Exclusion criteria

  • Patients with a history of allergy to local anesthetics.
  • Pre-existing neurological deficits in the lower extremities.
  • Coagulopathy or anticoagulation therapy that cannot be safely discontinued.
  • Infection at the site of block injection.
  • Severe obesity (BMI > 40).
  • Patients with contraindications to regional anesthesia.
  • peripheral neuropathy.
  • Psychiatric disorders and communication difficulties.

Treatment and study plan

AMM Group: Adductor Magnus Muscle Plane approach + Femoral Nerve Blocks

Procedure

In the supine position, the femoral nerve block will be conducted using a high-frequency ultrasound probe to identify the femoral nerve just below the fascia iliaca. After proper sterilization, the needle will be advanced in-plane to inject 15 ml bupivacaine 0.5% around the nerve. After performing the femoral nerve block, the adductor magnus muscle plane block will be performed using a low-frequency ultrasound probe positioned 6 cm distal to the inguinal crease to identify the sartorius muscle, femoral artery, femoral vein, and femoral nerve on the deep side of the sartorius muscle, the probe will be slide by about 2-2.5 cm distally, where we could identify the plane between the adductor magnus and the semimembranosus muscles, and after proper sterilization, the needle will be slowly advanced until the needle tip is close to the posterior surface of the AMM, 20 mL of bupivacaine 0.5% will be injected while observing fluid distribution under the posterior surface of the AMM, Then GA.

SG Group: Sciatic nerve block by sub-gluteal approach + Femoral nerve blocks

Procedure

While the patient is in the supine position, the femoral nerve block will be conducted using a high-frequency ultrasound probe to identify a cross-sectional view of the femoral nerve just below the fascia iliaca. After proper sterilization, the needle will be advanced in-plane to inject 15 ml bupivacaine 0.5% around the nerve. the patient will be turned on their sides with the operative side uppermost and flexed, the sub-gluteal sciatic nerve will be identified using a low-frequency probe, and then the same needle will be advanced the in-plane to inject 20 ml bupivacaine 0.5% around the nerve., then GA will be conducted as the other group

Primary outcomes

  1. Assessment of sciatic sensory block

    Time frame: At 30 minutes after the block

    It will be assessed by evaluating the sharp sensation with pinprick testing, and the presence or loss of cold-warm feeling as (2 for normal sensory perception, 1 for loss of cold-warm feeling, and 0 for loss of pinprick sensation) for ciatic in the sole of foot.

  2. Assessment of sciatic motor block

    Time frame: At 30 minutes after the block

    Sciatic block will be evaluated by the motion of the foot and ankle joint (3 for normal movement, 2 for unable to push or flex the foot against external resistance, 1 for unable to push or flex the foot against gravity and 0 for no motion

Secondary outcomes

  1. Postoperative pain scores

    Time frame: At 1, 6, 12, and 24 hours post-operative

    Using the Visual Analog Scale (VAS)

  2. The onset of sciatic sensory blockades

    Time frame: Every 3 minutes with maximum time 30 minutes (if no changes within 30 min the patient will be excluded from the study)

    Time in minutes from removing of the local anesthesia needle to the start of sensory changes

  3. The duration of the sciatic nerve block procedure

    Time frame: during sciatic nerve block conduction

    the time in minutes from the start of the sonographic examination for the sciatic nerve block until local anaesthetic administration.

  4. Visibility scores for the sciatic nerve

    Time frame: during sciatic nerve block using sub gluteal approach conduction

    using a 6-point visibility scale: 0: No nerve was identified

    • Nerve identified with a high probability
    • Nerve identified but most of it was not visible
    • Nerve identified and more than 50% of its borders were precisely distinguished from the surrounding structures
    • Nerve completely visible but fascicles poorly defined
    • Nerve completely visible and multiple fascicles identifiable

  5. Visibility scores for Adductor magnus muscle (AMM)

    Time frame: during sciatic nerve block using adductor magnus muscle plain block conduction

    using a 6-point visibility scale for AMM: 0: No muscle was identified

    • Muscle identified with a high probability
    • Muscle identified but most of it was not visible
    • Muscle identified and more than 50% of its epimysium were precisely distinguished from the surrounding structures
    • Muscle completely visible but perimysium poorly defined
    • Muscle completely visible and multiple perimysium identifiable

  6. Patient satisfaction

    Time frame: Before the patient discharge

    Using 4 degrees scale: excellent, good, sufficient, insufficient

  7. The onset of the Sciatic motor block

    Time frame: Every 3 minutes with maximum time 30 minutes (if no changes within 30 min the patient will be excluded from the study)

    Time in minutes from removing of the local anesthesia needle to the start of motor changes

Sponsors and collaborators

Lead sponsor

Mohammed Gaber Saad

Other

Registry information

Official study title

Efficacy of Adductor Magnus Muscle Plane Injection for Sciatic Nerve Block Versus Subgluteal Approach in Combination With Femoral Nerve Block in Knee Surgeries- A Randomized Control Study.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.